India's First Dengue Vaccine ‘Qdenga®’

The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare has approved first dengue vaccine for the prevention of dengue disease.

About Qdenga®

Qdenga® is a live, attenuated tetravalent dengue vaccine developed using recombinant DNA technology. The vaccine is produced in Vero cells, with genes encoding serotype-specific surface proteins engineered into a dengue virus type-2 backbone.

The product contains genetically modified organisms (GMOs). It is supplied as a freeze-dried powder for reconstitution and is administered as a subcutaneous injection.

The vaccine is indicated for the prevention of dengue disease in individuals 4 to 60 years of age. The recommended immunisation schedule consists of two doses of 0.5 ml each, administered at an interval of three months (0 and 3 months).

About Central Drugs Standard Control Organisation(CDSCO)

• It is the National Regulatory Authority (NRA) of India for the medical devices industry under the provisions of the Drugs and Cosmetics Act 1940.
• It is responsible for overseeing the import, manufacture, sale, and distribution of medical devices in the country. The CDSCO ensures that medical devices comply with safety, quality, and efficacy standards.
• It works under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. The Drugs Controller General of India (DCGI) is the head of the CDSCO.
• Under the Drugs and Cosmetics Act, CDSCO is responsible for, Approval of new drugs; Conduct of clinical trials; Laying down the standards for drugs; Control over the quality of imported drugs in the country; Coordination of the activities of State Drug Control Organizations;
• CDSCO, along with state regulators, is jointly responsible for the grant of licenses for certain specialized categories of critical drugs such as blood and blood products, I. V. Fluids, Vaccine, and Sera.
• It's headquarter in New Delhi.

Global clinical development programme

The approval is supported by evidence generated through an extensive global clinical development programme evaluating the vaccine's safety, immunogenicity and efficacy across both dengue-endemic and non-endemic regions.

Clinical studies were conducted in participants from more than eight countries, including Brazil, Thailand and Sri Lanka. The evaluation also included a pivotal Phase III safety and immunogenicity study conducted in the Indian population covering individuals aged 4 to 60 years.

The vaccine has already received regulatory approval in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand, and has also received World Health Organization (WHO) prequalification. Globally, more than 24 million doses of the vaccine have been distributed.

About Dengue 

Dengue is a mosquito-borne viral disease caused by the dengue virus of the Flavivirus genus. It is primarily transmitted by the bite of infected female Aedes mosquitoes, with Aedes aegypti being the main vector. 

• Its symptoms are Severe headache and pain behind the eyes  Intense bone, joint and muscle pain – often called “breakbone fever”  Nausea, vomiting, fatigue and skin rash  In severe cases: bleeding, organ damage and plasma leakage. The same mosquito species also spreads chikungunya, yellow fever and Zika virus.

According to the World Health Organization (WHO), dengue cases have increased sharply in recent decades. Many infections go unreported due to mild or asymptomatic presentation.

Conclusion

This vaccine marks an important milestone in India's public health response to dengue and is expected to complement the ongoing vector control, surveillance, early diagnosis and case management measures being implemented under the National Vector Borne Disease Control Programme.

This topic is equally significant for BPSC’s General Studies (GS) Paper (PT) and General Studies (GS) Paper II (Mains) as well.

Sources :- PIB